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Carbylan Biosurgery
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ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 is an FDA 510(k)-cleared medical device (K063308) manufactured by Carbylan Biosurgery. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 3, 2006. Regulation: 8.

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